510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213095Substantially Equivalent

andorate Suction Valve, andorate Air/Water Valve

GA Health Company Limited, Hong Kong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213095 is the FDA 510(k) clearance record for andorate Suction Valve, andorate Air/Water Valve, a class II device, cleared for Ga Health Company Limited on under FDA product code ODC (Endoscope Channel Accessory). FDA's definition for product code ODC reads: "To give the endoscope channel additional or improved functionality". FDA records list 12 510(k) clearances for Ga Health Company Limited, from to . As of , FDA records show no recalls naming K213095.

Clearance record

Decision date
Received
(110 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ga Health Company Limited Unit 18, 21/F, Metropole Sq., 2 On Yiu St., Shatin, Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODC

Trailing 12 months
1 clearance under product code ODC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260